Definition:Quality system focused on ensuring pharmaceutical products are consistently stored, transported, and handled under suitable conditions as required by regulatory authorities.
WHO GDP Guidelines: (adapted by SAHPRA for South Africa):
Key Requirements::
Quality Management::
- Written procedures for all operations
- Trained and qualified personnel
- Risk management approach
- Regular audits and reviews
- Temperature mapping of facilities and vehicles
- Continuous monitoring with calibrated equipment
- Deviation investigation and reporting
- Validated cold chain packaging
- Batch records and traceability
- Temperature logs and reports
- Deviation and CAPA (Corrective Action/Preventive Action) records
- Supplier and customer qualification
- IQ/OQ/PQ for equipment and vehicles
- Transport lane qualification
- SAHPRA licensing requirement for pharmaceutical distributors
- Required by pharmaceutical manufacturers
- Expected by healthcare providers
- Critical for patient safety
Temperature Control::
Documentation::
Qualification::
Why It Matters::
Related Terms:: SAHPRA, IQ/OQ/PQ, Temperature Mapping, Qualified Transport, Pharmaceutical Range
Resources:: GDP Compliance Guide
Find Services:: GDP-compliant pharmaceutical distributors and consultants